Tobacco Control has morphed into a crusade intent on demonizing both tobacco users and the industry supplying them. This blog examines and comments on scientific issues surrounding tobacco policies - and fallacies.

Friday, July 24, 2009

The FDA Crusade Against E-Cigarettes

On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…” The FDA report can be downloaded here.

For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agency’s new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.

The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and Njoy (there are many other manufacturers). With respect to “carcinogens,” the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; I’ll abbreviate the agents here as NNN, NNK, NAT and NAB.

I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.

The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the company’s products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that weren’t tested simply had blank boxes in the results chart. A footnote says, “Open boxes indicate the sample was not available for testing.” Another note in the methods section admitted that “…not all sample lots were available for analysis…as they were consumed in other testing.” In other words, the FDA didn’t purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe it’s a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.

The FDA tested 3 out of 4 Njoy products for TSNAs.

What the FDA didn’t test is even more important than what the agency tested. The report noted that the “Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.” That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didn’t test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, it’s been known for almost 20 years that nicotine medications contain TSNAs.

Why did the FDA analyze e-cigarettes for carcinogens, when there is no evidence the agency ever conducted carcinogen studies of products that they have regulated for over 20 years? Is it possible that the FDA approved medicines that contained TSNAs, but the agency is now disapproving e-cigarettes because they contain the same contaminants? To answer this important question, we have to know how high – or how low – the TSNA levels are in these products.

Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?

So what does “Detected” mean in the FDA analysis? In other words, what was the lowest TSNA concentration that the test detected?

As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION.

The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.

In summary, the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.

These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes. According to Dr. Murray Laugesen, a respected New Zealand researcher, “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

Over 400,000 American Citizens Die every year! So if the FDA really cares about it's citizens then it should Ban Traditional Tobacco smoking before Closing it's Doors on a Simple device called an Electronic Cigarette which Has not yet harmed a single human since it was introduced in 2004. I've been a tobacco smoker all my life and this simple device made me quit smoking Tobacco for good so I can freely suggest to those who are considering a much better & safer alternative to give an electronic Cig a try. Please care about your health & the environment, :) I purchased my electronic Cig from http://www.ElectronicCig.com

You guys made great comments for this subject. I think politics should not interact with the use of an electronic cigarette since conventional tobacco smoking has proved on breing the most deadliest product know to man kind for centuries. Our new generation needs a much safer alternative to smoking, a solution has been invented that's calledelectronic cigarette which has not killed nor harmed a single human in 5 years of it's making! So please choose what's safe for you & the environment!!!

My big issue with the FDA is that they only tested Chinese smoke juice, and made a blanket statement that all Electronic Cigarette products are dangerous. So what if they found antifreeze in Chinese e-liquid, did we forget that they also put lead in our kids toys!? Why didn't the FDA test any American Made electronic cigarette e-liquid like Halo or Johnson Creek? I bet these would have came back without any incriminating issues.

I simply can not understand why the governmant would want to regulate the e-cigs. Like Dr. Murray Laugesen said above “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

Duh People. Let's look at this. Cigarrets are addictive. It's a hard habit to break. And they are outragously expensive (taxed). And they cause cancer. E-cigs have helped people quit. They are giving them away. And they appear to be harmless.

So, smoke regular cigs, pay lot of money to the Government, get cancer and die young. OR Smoke E-cigs, pay little money to the Government, possibly quit and live a full and happy life.

Whatever they find in an e-cig most likely is contained in a real tobacco cigarette. So, it seems basic. Ban e-cigarettes and you'll have to ban real cigarettes. That will never happen, because there is too much money at stake in profits, and taxes.

I have been historically a supporter of government regulation. It has done good for a number of people. But, this is a clear case of fraud and not science. I'm not saying ecigs are safe. But I would like to know. I can only guess that tax revenue and lobby money is playing into the FDA and the lack of true peer reviewed research. What a scam. I say regulate the ecig companies and test their products -- if they don't contain what they say, fine them, take away a license or whatever. Imagine if a safe alternative to smoking is at hand that allows people to enjoy the pleasure of nicotine! The government can tax nicotine, who cares? Lets get to the science.

there is only one way to close this discussion: to perform a prospective study in which the risk for cancer, lung disease and cardiovascluar events are compared between traditional smokers and e-cig smokers. Why such a trial has not been performed or proposed by FDA? Maybe it is because someone fears it will clearly show e-cig safety? And then, what will happen to tobacco brands like Marlboro?

it is not about health it is about greed, lies, and politics. e cigs help and are better than cigarettes. the tax money alone that will be lost if we all switch is unreal not to mention the tobacco company will fall if they don't switch too. it is jobs and more. its not about saving lives like me. E cigs are the new way to quit and the new way to keep enjoying.E cigs need to be properly regulated and taxed correctly and not considered a tobacco product. nicotine is not tobacco. it is a byproduct. cigarettes have more addictive things other than nicotine. i have felt that since i switched and have fought threw them and now feel good. now just have to get off the nicotine.

My Credentials

I am a Professor of Medicine at the University of Louisville, I hold an endowed chair in tobacco harm reduction research, and I am a member of the James Graham Brown Cancer Center at U of L.

For the past 20 years I have been involved in research and policy development regarding tobacco harm reduction (THR). THR advocates acknowledge that there are millions of smokers who are unable or unwilling to quit with conventional cessation methods involving tobacco and nicotine abstinence, and we encourage them to use cigarette substitutes that are far safer.

My research has appeared in a broad range of medical and scientific journals. I have authored commentaries in the general press and I wrote the book, For Smokers Only: How Smokeless Tobacco Can Save Your Life. In 2003 I served as an expert witness at a Congressional hearing on tobacco harm reduction, and I have spoken at numerous international forums, including one held in London at the British Houses of Parliament.

My research is supported by unrestricted grants from tobacco manufacturers to the University of Louisville and by the Kentucky Research Challenge Trust Fund.